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A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors (IVY)

Primary Purpose

Melanoma, Prostate Cancer, Ovarian Cancer

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pegilodecakin
Paclitaxel or Docetaxel and Carboplatin or Cisplatin
FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
gemcitabine/nab-paclitaxel
Capecitabine
Pazopanib
Pembrolizumab
Paclitaxel
nivolumab
Gemcitabine/carboplatin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Phase 1/Phase 1b, Oncology, Cancer, Solid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Part A Escalation Cohorts:

o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies

Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts:

  • Tumors with all histological diagnosis or tissue origin may be enrolled

  • Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease.

    • Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC)
    • At least 18 years of age
    • Performance Status of 0 or 1
    • Adequate organ function

Exclusion Criteria:

  • Hematologic malignancies
  • Pregnant or lactating
  • Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders
  • Myocardial infarction within the last 6 months
  • Unstable angina, or unstable cardiac arrhythmia requiring medication
  • Surgery within the last 28 days
  • Systemic fungal, bacterial, viral, or other infection
  • History of bleeding diathesis within the last 6 months
  • Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B

Sites / Locations

  • UCLA Medical Hematology & Oncology
  • UCSF
  • Sarah Cannon Research Institute at HealthONE
  • Florida Cancer Specialists & Research Institute
  • Dana Farber Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
  • Sarah Cannon Research Institute
  • The University of Texas M.D. Anderson Cancer Center
  • South Texas Accelerated Research Therapeutics

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm 17

Arm 18

Arm 19

Arm 20

Arm 21

Arm 22

Arm 23

Arm 24

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Dose Escalation Cohort 1

Part A: Dose Escalation Cohort 2

Part A: Dose Escalation Cohort 3

Part A: Dose Escalation Cohort 4

Part A: Dose Escalation Cohort 5

Part A: Dose Escalation Cohort 6

Part A: Dose Expansion Cohort 1

Part B: Dose Escalation Cohort 1

Part B: Dose Escalation Cohort 2

Part B: Dose Escalation Cohort 3

Part B: Dose Expansion Cohort

Part C: Dose Escalation Cohort 1

Part C: Dose Escalation Cohort 2

Part C: Dose Escalation Cohort 3

Part C: Dose Expansion Cohort 1

Part D: Dose Escalation Cohort 1

Part E: Dose Escalation Cohort 1

Part F: Dose Escalation Cohort 1

Part G: Dose Escalation Cohort 1

Part H: Dose Escalation Cohort 1

Part I: Dose Escalation Cohort 1

Part H: Dose Escalation Cohort 2

Part H: Dose Escalation Cohort 3

Part J: Dose Escalation Cohort 1

Arm Description

Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months

Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months

at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV

Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours

Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.

Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID

Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD

Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min

Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min

Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes

Outcomes

Primary Outcome Measures

Safety and tolerability as measured by incidence of adverse events
Pharmacokinetic (PK) parameters
PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).

Secondary Outcome Measures

Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)
Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)
Anti-Pegilodecakin antibody formation

Full Information

First Posted
December 2, 2013
Last Updated
November 15, 2022
Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences
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1. Study Identification

Unique Protocol Identification Number
NCT02009449
Brief Title
A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors
Acronym
IVY
Official Title
A Phase 1, Open-Label Dose Escalation First-in-Human Study to Evaluate the Tolerability, Safety, Maximum Tolerated Dose, Preliminary Clinical Activity and Pharmacokinetics of AM0010 in Patients With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2013 (Actual)
Primary Completion Date
February 19, 2019 (Actual)
Study Completion Date
November 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
ARMO BioSciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a first-in-human, open-label, dose escalation study to evaluate the safety and tolerability of pegilodecakin in participants with advanced solid tumors, dosed daily subcutaneously as a monotherapy or in combination with chemotherapy or immunotherapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Prostate Cancer, Ovarian Cancer, Renal Cell Carcinoma, Colorectal Carcinoma, Pancreatic Carcinoma, Non-small Cell Lung Carcinoma, Solid Tumors, Breast Cancer
Keywords
Phase 1/Phase 1b, Oncology, Cancer, Solid Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (1 ug/kg) - Daily subcutaneous (SC) injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Escalation Cohort 2
Arm Type
Experimental
Arm Description
Pegilodecakin (2.5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Escalation Cohort 3
Arm Type
Experimental
Arm Description
Pegilodecakin (5 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Escalation Cohort 4
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Escalation Cohort 5
Arm Type
Experimental
Arm Description
Pegilodecakin (20 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Escalation Cohort 6
Arm Type
Experimental
Arm Description
Pegilodecakin (40 ug/kg) - Daily subcutaneous injections of pegilodecakin for up to 22 months
Arm Title
Part A: Dose Expansion Cohort 1
Arm Type
Experimental
Arm Description
at least 15 RCC participants will be dosed with pegilodecakin for up to 22 months
Arm Title
Part B: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Arm Title
Part B: Dose Escalation Cohort 2
Arm Type
Experimental
Arm Description
Pegilodecakin (5 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Arm Title
Part B: Dose Escalation Cohort 3
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Arm Title
Part B: Dose Expansion Cohort
Arm Type
Experimental
Arm Description
Daily SC injection with pegilodecakin with Platinum / Taxane combination Every 21 days, (21 days = 1 cycle) for 5 cycles. Day 1 Paclitaxel 200/175 mg/m2 IV, or Docetaxel 75/65 mg/m2 IV And Carboplatin AUC 6/5/4 (max. 6x 150mg) IV or Cisplatin 75mg/m2 IV
Arm Title
Part C: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (2.5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Arm Title
Part C: Dose Escalation Cohort 2
Arm Type
Experimental
Arm Description
Pegilodecakin (5 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Arm Title
Part C: Dose Escalation Cohort 3
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with FOLFOX4 every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Arm Title
Part C: Dose Expansion Cohort 1
Arm Type
Experimental
Arm Description
Daily SC injection with pegilodecakin with FOLFOX4 Every 14 days FOLFOX4; (14 days = 1 cycle) ; Day 1 Oxaliplatin 85 mg/m2 IV over 2 hours Leucovorin 200 mg/m2 IV over 2 hours followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours Leucovorin 200 mg/m2 IV over 2 hours on Day 2 followed by 5-FU 400 mg/m2 IV bolus and 5-FU 600 mg/m2/day IV over 22 hours
Arm Title
Part D: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (5 ug/kg) daily subcutaneous injections with Gemcitabine and nab-paclitaxel on Days 1, 8, 15 of each cycle (28 days = 1 cycle). Nab-paclitaxel 125 mg/m2 IV over 30 minutes followed by • Gemcitabine 1000 mg/m2 IV.
Arm Title
Part E: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with capecitabine BID daily for 14 days of each cycle (21 days= 1 cycle). • Capecitabine 1000 mg/m2 po BID
Arm Title
Part F: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with paclitaxel on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
Arm Title
Part G: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with pazopanib orally given daily for 14 days of each cycle (21 days= 1 cycle) • Pazopanib 800 mg po QD
Arm Title
Part H: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Arm Title
Part I: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (20 ug/kg) daily subcutaneous injections with nivolumab on Day 1 of each cycle (14 days= 1 cycle). • Nivolumab 3 mg/kg IV over 60 min
Arm Title
Part H: Dose Escalation Cohort 2
Arm Type
Experimental
Arm Description
Pegilodecakin (20 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Arm Title
Part H: Dose Escalation Cohort 3
Arm Type
Experimental
Arm Description
Pegilodecakin (40 ug/kg) daily subcutaneous injections with pembrolizumab on Day 1 of each cycle (21 days= 1 cycle). • Pembrolizumab 2 mg/kg IV over 30 min
Arm Title
Part J: Dose Escalation Cohort 1
Arm Type
Experimental
Arm Description
Pegilodecakin (10 ug/kg) daily subcutaneous injections with gemcitabine and carbolplatin on Days 1,8 of each cycle (21 days=1 cycle) until disease progression gemcitabine 1000mg/m2 IV over 30 minutes followed by carboplatin AUC2 over 60 minutes
Intervention Type
Drug
Intervention Name(s)
Pegilodecakin
Other Intervention Name(s)
LY3500518, AM0010, PEGylated recombinant human Interleukin-10, PEG-rHuIL-10
Intervention Description
Daily subcutaneous injections of pegilodecakin up to 12 months
Intervention Type
Drug
Intervention Name(s)
Paclitaxel or Docetaxel and Carboplatin or Cisplatin
Other Intervention Name(s)
Taxol or taxotere and paraplatin or platinol
Intervention Description
Day 1 of every 21 day cycle
Intervention Type
Drug
Intervention Name(s)
FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)
Other Intervention Name(s)
Eloxatin®/Leucovorin/5-FU
Intervention Description
Intravenous administration on Day 1 and 2 of every 14 day cycle
Intervention Type
Drug
Intervention Name(s)
gemcitabine/nab-paclitaxel
Other Intervention Name(s)
Gemzar/Abraxane ABI-007
Intervention Description
Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
GW786034
Intervention Description
Pazopanib will be administered orally daily continuously
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Other Intervention Name(s)
Keytruda, MK-3475
Intervention Description
Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle) • Paclitaxel 80 mg/ m2 IV
Intervention Type
Drug
Intervention Name(s)
nivolumab
Other Intervention Name(s)
Keytruda
Intervention Description
Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
Intervention Type
Drug
Intervention Name(s)
Gemcitabine/carboplatin
Other Intervention Name(s)
gemzar/paraplatin
Intervention Description
gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
Primary Outcome Measure Information:
Title
Safety and tolerability as measured by incidence of adverse events
Time Frame
up to 12 months
Title
Pharmacokinetic (PK) parameters
Description
PK parameters including the serum trough concentration (Minimal Drug Concentration (Cmin)), the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½).
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Change in tumor burden measured by volumetric Computer Tomography (CT) or Magnetic Resonance Imaging (MRI) according to immune-related response criteria (irRC)
Time Frame
up to 12 months
Title
Progression in bone by bone scintigraphy according to Prostate Cancer Working Group 2 (PCWG2) for participants with metastatic castration resistant prostate cancer (CRPC)
Time Frame
approximatley 4 months
Title
Anti-Pegilodecakin antibody formation
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Part A Escalation Cohorts: o Histologically or cytologically confirmed advanced malignant solid tumor, limited to melanoma, castrate resistant prostate cancer (CRPC), ovarian cancer (OVCA), renal cell carcinoma, colorectal carcinoma (CRC), pancreatic carcinoma or non-small cell lung carcinoma (NSCLC) that is refractory to, intolerant of, for which no standard of therapy is available or where the participant refuses existing therapies Part A Expansion Cohorts, Part B and C Escalation and Expansion Cohorts: Tumors with all histological diagnosis or tissue origin may be enrolled Participants must have failed prior standard curative chemotherapy for their disease, refuse existing therapies OR the proposed chemotherapy regimen to which pegilodecakin is added represents an acceptable standard treatment for their disease. Measurable or evaluable disease according to irRC or bone metastatic disease evaluable by Prostate Cancer Working Group 2 criteria (PCWG2) for castration-resistant prostate cancer (CRPC) At least 18 years of age Performance Status of 0 or 1 Adequate organ function Exclusion Criteria: Hematologic malignancies Pregnant or lactating Present or history of neurological disorders such as Multiple Sclerosis and Guillain Barre or inflammatory central nervous system/peripheral nervous system (CNS/PNS) disorders Myocardial infarction within the last 6 months Unstable angina, or unstable cardiac arrhythmia requiring medication Surgery within the last 28 days Systemic fungal, bacterial, viral, or other infection History of bleeding diathesis within the last 6 months Positive for human immunodeficiency virus (HIV), hepatitis C, or hepatitis B
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Hematology & Oncology
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
UCSF
City
San Francisco
State/Province
California
Country
United States
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Florida Cancer Specialists & Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Stephenson Cancer Center at Oklahoma University TSET Phase 1 Program
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
South Texas Accelerated Research Therapeutics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31563517
Citation
Naing A, Wong DJ, Infante JR, Korn WM, Aljumaily R, Papadopoulos KP, Autio KA, Pant S, Bauer TM, Drakaki A, Daver NG, Hung A, Ratti N, McCauley S, Van Vlasselaer P, Verma R, Ferry D, Oft M, Diab A, Garon EB, Tannir NM. Pegilodecakin combined with pembrolizumab or nivolumab for patients with advanced solid tumours (IVY): a multicentre, multicohort, open-label, phase 1b trial. Lancet Oncol. 2019 Nov;20(11):1544-1555. doi: 10.1016/S1470-2045(19)30514-5. Epub 2019 Sep 25. Erratum In: Lancet Oncol. 2019 Dec;20(12):e663.
Results Reference
derived
PubMed Identifier
27528724
Citation
Naing A, Papadopoulos KP, Autio KA, Ott PA, Patel MR, Wong DJ, Falchook GS, Pant S, Whiteside M, Rasco DR, Mumm JB, Chan IH, Bendell JC, Bauer TM, Colen RR, Hong DS, Van Vlasselaer P, Tannir NM, Oft M, Infante JR. Safety, Antitumor Activity, and Immune Activation of Pegylated Recombinant Human Interleukin-10 (AM0010) in Patients With Advanced Solid Tumors. J Clin Oncol. 2016 Oct 10;34(29):3562-3569. doi: 10.1200/JCO.2016.68.1106.
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A Phase 1 Study of Pegilodecakin (LY3500518) in Participants With Advanced Solid Tumors

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